CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
Lamivudine, nevirapine, and stavudine fixed-dose tablet +3 moredrug
Likely dose
Lamivudine, nevirapine, and stavudine fixed-dose tablet 7 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00312091
NCT00312091Phase 2Completed
CompareCT.gov

A Phase I/II Comparative Pharmacokinetic Study of the Fixed-Dose Combination (FDC) of Stavudine (d4T), Lamivudine (3TC), and Nevirapine (NVP) as GPO-VIR Pediatric Chewable Tablets Versus the Individual Liquid Formulations in HIV Infected Children 6 Months and Older to Less Than 13 Years of Age in Thailand

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Apr 7, 2006·Updated Nov 2, 2021

In Brief

A Phase 2 clinical trial evaluating Lamivudine, nevirapine, and stavudine fixed-dose tablet, Lamivudine, and 2 other interventions for HIV Infections. Completed, enrolled 44 participants across 4 sites.

Detailed Summary

The purpose of this study is to compare the blood levels, absorption, and breakdown of lamivudine (3TC), nevirapine (NVP), and stavudine (d4T) in a fixed-dose tablet to that of the individual liquid formulations of the same anti-HIV drugs in HIV infected Thai children.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesThailand
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 7, 2006
Enrollment StartDec 1, 2006
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 20.2 years ago

Interventions

Lamivudine, nevirapine, and stavudine fixed-dose tabletdrug

7 mg d4T, 30 mg 3TC, 50 mg NVP tablet

Lamivudinedrug

Dosage dependent on weight. More information on this criterion can be found in the protocol.

Nevirapinedrug

Dosage dependent on weight. More information on this criterion can be found in the protocol.

Stavudinedrug

Dosage dependent on weight. More information on this criterion can be found in the protocol.